EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure EMPEROR-Preserved

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 11583

Inclusion Criteria

- Patients with chronic HF diagnosed for at least 3 months before Visit 1 and currently in HF New York Heart Association (NYHA)class II-IV
- Chronic HF with preserved EF defined as LVEF > 40 % per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, MRI or CT), and no prior measurement of LVEF = 40% under stable conditions. The EF must have been obtained and documented at Visit 1 or within 6 months prior to Visit 1, and more than 90 days after any Myocardial Infarction.
- Elevated N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
- Patients must have at least one of the following evidence of HF:
a) Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1,
OR
b) Documented hospitalisation for HF (HHF) within 12 months prior to Visit 1
- Oral diuretics, if prescribed to patient according to local guideline and discretion of the Investigator, should be stable for at least 1 week prior to Visit 2 (Randomisation)
- eGFR (CKD-EPI)cr = 20 mL/min/1.73m2 at Visit 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2063
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2063

Exclusion Criteria

1. Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
2. Heart transplant recipient or listed for heart transplant
3. Implantation of cardioverter defibrillator (ICD) within 3 months prior to Visit 1
4. Implanted cardiac resynchronisation therapy (CRT)
5. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic
obstructive cardiomyopathy or known pericardial constriction
6. Any severe valvular heart disease expected to lead to
surgery during the trial in the Investigator’s opinion
7. Acute decompensated HF requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 1 week from discharge to Visit 1, and during screening period until Visit 2 (Randomisation)
8. Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 2 (Randomisation)
9. Systolic blood pressure (SBP) = 180 mmHg at Visit 2. If SBP >150 mmHg and <180 mmHg at Visit 2, the patient should be receiving at least 3 antihypertensive drugs
10. Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 or Visit 2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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